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Feasibility and safety of EGFR-TKI neoadjuvant therapy for EGFR-mutated NSCLC: A meta-analysis
Zhuchen Yu1, Fei Xu2, Juntao Zou3
1Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.
Background:
The role of neoadjuvant epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) targeted therapy for EGFR-mutated non-small cell lung cancer (NSCLC) is unclear. Previous studies have shown that EGFR-TKIs have excellent anti-tumor activity. However, almost all studies on neoadjuvant EGFR-TKI treatment for EGFR-mutated NSCLC have been non-randomized controlled trials with small sample sizes and different methods of statistical analysis, which may lead to a lack of valid metrics to assess the feasibility and safety of neoadjuvant EGFR-TKI treatment. This meta-analysis aimed to assess the efficacy and safety of neoadjuvant EGFR-TKI treatment for NSCLC patients with EGFR mutations.
Methods:
Relevant studies were systematically searched in PubMed, Embase, and Web of Science databases. Results including objective response rate (ORR), complete resection rate (R0), downstaging rate, pathological complete response (PCR), major pathological response (MPR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were used for further analysis.
Results:
This meta-analysis ultimately included 11 studies involving 344 patients with EGFR-positive mutations in NSCLC. In terms of tumor response, the pooled ORR was 57% (95% CI: 42%-73%), and in the Osimertinib subgroup, the pooled ORR was 80% (95% CI: 63%-98%). Analysis of studies that reported a downstaging rate showed the pooled downstaging rate of 41% (95% CI: 9%-74%) and the pooled downstaging rate of 74% (95% CI: 22%-100%) in the Osimertinib subgroup. In terms of surgical outcomes, the pooled pCR rate was 3% (95% CI: 0%-7%), the pooled MPR rate was 11% (95% CI: 6%-17%), and the pooled R0 resection rate was 91% (95% CI: 85%-95%). The most common adverse events associated with neoadjuvant therapy were rash and diarrhea. The pooled incidence of any grade of rash was 47.1% (95% CI: 25.4%-69.3%), and the pooled incidence of grade ≥ 3 rash was 0.6% (95% CI: 0.0%-2.5%). The pooled incidence of diarrhea of any grade was 28.8% (95% CI: 14.4%-45.4%), with the pooled incidence of grade ≥ 3 diarrhea of 0.2% (95% CI: 0.0%-1.6%). The pooled incidence of ≥ grade 3 adverse events was significantly lower.
Conclusions:
Our meta-analysis confirmed the efficacy and safety of neoadjuvant EGFR-TKIs for the treatment of NSCLC patients with EGFR-positive mutations and that third-generation EGFR-TKIs were superior to first- and second-generation EGFR-TKIs in terms of shrinking tumor volume and lowering tumor stage; however, future large-scale and multicenter randomized controlled trials are needed to confirm this conclusion.
Systematic Review Registration:
PROSPERO CRD42023466731.
Insights
Neoadjuvant epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) therapy shows efficacy and safety in EGFR-mutated non-small cell lung cancer (NSCLC). Third-generation EGFR-TKIs demonstrate superior tumor reduction and downstaging compared to earlier generations.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- The efficacy and safety of neoadjuvant epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) targeted therapy for EGFR-mutated non-small cell lung cancer (NSCLC) remain incompletely understood.
- Previous research indicates significant anti-tumor activity of EGFR-TKIs, but limitations in study design (small sample sizes, non-randomized controlled trials) hinder definitive assessment of neoadjuvant treatment feasibility and safety.
- This meta-analysis was conducted to evaluate the efficacy and safety of neoadjuvant EGFR-TKI treatment in NSCLC patients with EGFR mutations.
Approach:
- A systematic literature search was performed across PubMed, Embase, and Web of Science databases.
- Data extracted included objective response rate (ORR), complete resection rate (R0), downstaging rate, pathological complete response (pCR), major pathological response (MPR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
- Statistical analysis was employed to pool and analyze the collected data from relevant studies.
Key Points:
- The meta-analysis included 11 studies with 344 patients, revealing a pooled ORR of 57% (42%-73%), with the Osimertinib subgroup showing an 80% (63%-98%) ORR.
- Surgical outcomes demonstrated a pooled pCR rate of 3% (0%-7%), MPR rate of 11% (6%-17%), and R0 resection rate of 91% (85%-95%).
- The most frequent adverse events were rash (47.1%) and diarrhea (28.8%), with a significantly lower incidence of grade ≥3 adverse events.
Conclusions:
- Neoadjuvant EGFR-TKIs are effective and safe for treating EGFR-mutated NSCLC patients.
- Third-generation EGFR-TKIs, such as Osimertinib, show superiority over first- and second-generation agents in reducing tumor volume and downstaging.
- Further large-scale, multicenter randomized controlled trials are necessary to validate these findings.
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